Drug Shortages and the Joint Commission Stance

Periodically there have been drug shortages in the United States, which comes as a surprise to many. There are a number of reasons for this.

Recently one of my company’s pharmacists informed the physicians in my group of a nationwide shortage of bupivicaine and lidocaine, medications used for anesthesia, similar to what your dentist may give you before drilling your tooth.

I suggested that maybe we should be allowed to use such products past the expiration date until the shortage was resolved. They replied that they can’t do that because of Joint Commission standards.

So I wrote to the Joint Commission and eventually spoke with a nurse there. Their position was that it’s not safe to use a drug past its expiration date and they were just following guidelines by the Food and Drug Administration and others. I said that although I would generally agree that it is preferable not to use expired medications, in the case of shortages that may not be the case.

Imagine you have a life threatening infection with a bacterial organism resistant to all antibiotics but one, and there is a shortage of that antibiotic. In fact the hospital you are in has a box of antibiotics that expires at midnight tonight. They can give you only one dose then will have to throw away the rest, even though antibiotics would normally be given for 10 days and they don’t know when they will be able to get more.

Are you really safer as a result of throwing away the rest of the vials of the only antibiotic to treat your infection? In the interest of fair and balanced discussion I admit that I’ve eaten tuna fish after the date stamped on the can. But seriously, the risk of a complication from a slightly outdated medication is almost non-existent, and certainly less than the risk of going without.

Physicians going on medical missions to third world countries used to bring with them expired medications to administer to patients, the thought being that they were safe and better than nothing. Due to liability concerns, that pretty much doesn’t happen anymore, a fact said Joint Commission nurse brought up. In fact a 1997 article in the New England Journal of Medicine pointed out that at least half of the drugs donated to the Bosnian conflict were unusable because they had expired, and said pharmaceutical companies may have dumped the medications to get tax write offs and avoid disposal costs. That may have been the case, and could be addressed by not granting write offs for expired drugs, but that doesn’t mean they couldn’t have safely used the medications.

A 1979 law required pharmaceutical companies to give a date they guarantee the full potency and safety of a drug. They stand to gain financially when customers throw away good medicine because it has, “expired”. In fact the military conducted a study to see if they could extend how long they keep medications in order to cut back on the cost of destroying and replacing a billion dollars of inventory every 2-3 years. They found that 90% of the more than 100 drugs they tested were safe and effective up to 15 years after the expiration date. This program is now used by the Department of Defense, the Department of Veteran Affairs, the US Postal Service and the Bureau of Federal Prisons.

The nurse at the Joint Commission pointed out that I could decide whether the risk was warranted to use an expired drug. But in reality, I don’t get the chance to even discuss it with a patient to give them a choice. Hospitals risk a large financial penalty, and potentially even being shut down, for violating Joint Commission standards. Those drugs are going to go in the trash the day before they expire, shortage or no shortage.

I think the Joint Commission should modify their standards. At the least it should say that drugs should not be used after the expiration date unless their are shortages, or delivery problems due to disaster, in which case the medications should only be used if there are not suitable alternatives, and it’s felt that the benefits exceed the risks.

Surprising HIPAA Violation

The Health Information Portability Act (HIPAA) has criteria about not violating patient privacy, and potential harsh penalties for doing so. One needs to not only avoid saying a patient’s name to the public (meaning people not involved in the patient’s care), but not even to provide enough identifying information to allow someone to identify a patient. If you say you saw a 45-year-old male architect for diabetes, and there aren’t that many architects in town, you’ve probably supplied enough information for someone to figure out who you’re talking about.

I’m usually pretty conscious of it, and some of my colleagues are used to me ‘coughing’ “HIPAA” when they say a patient’s name aloud. One day, however, while eating lunch with my colleagues, I told the story of an 80+ man who came in complaining of a large bruise on his leg that he sustained after a fall when he tripped while running backwards. One of my colleagues said, “Was that Bob Smith*?”

“How did you know?” I asked.

“We go on the ski bus together and after he gets off he always runs backwards around the bus!”

*Not his real name, and yes, I got his permission to post this story.

Obamacare and the Supreme Court

This week the Supreme Court agreed to hear a legal challenge to the healthcare reform law, colloquially known as ‘Obamacare”. They have scheduled 5 1/2 hours for oral arguments, dividing the law into four parts, that they will hold over two days. According to a number of articles, this is pretty much unprecedented in modern history. Since 1970 the typical case is allotted one hour for oral arguments, with 30 minutes for each side.

I’m not a lawyer, but I was astounded by these numbers. I realize that the Supreme Court justices spend a lot of time reading written briefs, and probably have internal discussions, but only spending an hour listening to arguments for an issue that has hit the highest court of the nation does not sound like much time to me. If I have a complicated patient in my office, it’s not so unusual that I end up spending an hour on them, and unless they are going on Hospice, they always get a follow-up visit. The Supreme Court gets about 10,000 petitions a year, and only rules on a small fraction of them. Before it gets to that level, many lawyers and judges have already debated the issues, and if the answer was obvious, it would probably have been settled. It seems stingy to me to only giving one hour for oral arguments for cases at that level.

Even 5 1/2 hours doesn’t sound like much. The 12 members of the debt reduction super committee couldn’t come to an agreement on debt reduction after working on the issue for more than 3 months. That’s far more time than the Supreme Court will spend working on the health care law, and I’m not sure that it’s that much less complex than dealing with debt reduction. Of course the justices have the great advantage of not having to worry about getting re-elected.

Medicaid Documentation Nightmare

Washington State Medicaid has new requirements for ordering imaging tests. I ordered a dobutamine Cardiolite stress test for one of my patients. The coder in my office brought me the Cardiac Imaging Questionnaire – CarePlanner/iEX form. It had 41 questions which she gave to me because she can’t tell from the chart how to fill it out! As it turned out I didn’t have to answer all the questions, but it still took a while to figure out what questions I needed to answer and look up the information in the chart.

Physicians usually lose money when seeing patients on Medicaid since the reimbursement is less than the cost. Add in ridiculous paperwork burdens, and they may find that primary care doctors start referring their patients to specialists rather than do the test themselves. Then the Washington State Department of Social and Health Services (DSHS) can pay for the cardiology consult instead, to be followed by the test I wanted to do in the first place, or a more costly cardiac catheterization. If I think a patient needs a test, it’s pretty rare when the specialist does not agree that the patient needs that, or a more expensive test, done. Making it more cumbersome for primary care physicians will likely ultimately raise costs, not decrease them.

Let the Sunshine In, Let the Sunshine In

A GlaxoSmithKline representative came by to drop off samples in my office and asked if there was anything else they could do for us. GSK makes some inhalers so I asked if they could supply spacers to give to patients, something they used to do. Spacers come in different designs, but basically it’s a plastic tube that fits between an inhaler, such as albuterol, and the mouth. The extra distance causes the medication particles to get smaller, so they deposit deeper in the lungs. The spacers are relatively inexpensive, probably less than the cost of the inhaler for a week, and can last years, but because insurance companies usually don’t cover them, patient’s usually don’t get them. Handing one out in the physician office is a good way to get patients to use one, plus the proper use can be demonstrated in the office.

The representative said that his company was not giving the spacers, and in light of the Physician Payment Sunshine Act, doubted they would. This proposed regulation of the Centers for Medicare and Medicaid Services (CMS), part of Section 6002 of the Affordable Care Act, stipulates that, effective 3/1/12, that pharmaceutical companies report payments to physicians over $10. It makes no difference whether the spacers are for the physician, or their patients.

The purpose of the Physician Payment Sunshine Act is to discourage physicians from making prescription decisions based on financial inducements. Just to be clear, pharmaceutical companies don’t just give physicians cash to prescribe their medications, which would clearly be immoral, if not illegal, but can give other incentives in the form of meals, books, speaking fees, etc. In this case, however, the reporting requirements are not consistent and don’t make sense. They don’t have to report leaving samples of their inhaler, which costs far more than a spacer, but they would have to report the spacer, even though it could be used with inhalers made by other manufacturers. Although in balance I like having samples, they tend to encourage one to prescribe them since we don’t have generic samples. I think insurance companies would save money providing free generic samples, but that’s another story.

The bill was introduced by senators Charles Grassley, R-Iowa, and Herb Kohl, D-Wisconsin. As recently reported by 60 Minutes, congressmen can legally trade on insider information, so this law was hypocritical (in fact I see that only 25% of the Sunshine Act sponsors senators are sponsoring the Stop Trading on Congressional Knowledge Act  S.1871 or S.1903 bills) . But as physicians we are ‘Hippocratical‘ and hold ourselves to a higher standard. That said, I think there are many instances where it’s legitimate for physicians to accept items of value from pharmaceutical companies.

The science of medicine advances at a fast rate, and it’s difficult, if not impossible, to keep up to date. This is true for specialists, and even more so for primary care physicians. The majority of medications I prescribe every day were not available when I was a resident in training. One way I help stay up to date is to listen to pharmaceutical representatives, or physicians they bring in, while I eat a meal they provide. There is no quid pro quo agreement to prescribe their medications, and many a rep can attest that I frequently challenge what they say. But what they do get is some of my time and a chance to present information that ultimately may benefit my patients. True, there are other ways to get the information, but time is the problem. I have to eat, so that’s a good time to talk. Listening to top physicians they’ve flown in, and having the opportunity to ask questions, is very valuable. I also participate in research trials (needed to create new medications), and those fees will show up in the database. The act would not make such payments illegal, but the concern is that the public will not be able to put the numbers in context and it may incorrectly imply impropriety.

Physicians and other providers do need to be careful they are not unduly biased by pharmaceutical companies, and I have a lot of concerns about pricing manipulations of medical drugs, but when it comes to the Physician Payment Sunshine Act, I think it’s pointing a light at the wrong place, or at least with too broad a beam.

Free Speech and Off-Label Drug Use

When pharmaceutical representatives talk to physicians and others about their products, they are only allowed to talk about indications (reasons) to use the product as approved by the Food and Drug Administration. Doctors are free to prescribe for other reasons, and often do so for good reasons.  Drug companies may pay dearly if they break the rules. Pfizer paid 2.3 billion due to promoting Bextra for off-label use, for example.

This rule was put into effect decades ago to protect consumers. Since then there have been a number of examples of products promoted for things that in retrospect didn’t work as advertized. If you’re old enough, you’ve probably heard the term snake oil.

According to the Wall Street Journal there are now several court cases that may change these rules. In June the U.S. Supreme Court struck down a Vermont law and cited the First Amendment in a case involving pharmacies sharing data with pharmaceutical companies to help them market their drugs to doctors. That has opened the door for the companies to now claim the same free speech rights to market drugs off-label.

If the companies gain this ability, it would be bad for patients. Basically they could say whatever they want. Besides talking about off label use where there is legitimate reasons to use their product, they could claim anything they wanted to say. “Our drug is more effective than our competitor,” even if it’s not. “Our drug is perfectly safe,” even if it’s not. “Our drug will make you lose weight, increase your IQ, improve your looks, and make you live 10 years longer, “even if it won’t, but if you believe it, let me tell you about a bridge for sale.

I learn about a lot of new drugs because the sales reps come to my office to tell me about their product. As it is, I listen to them skeptically and off challenge what they say. Although they are restricted on what they can say, they can choose what information to emphasize and how to make their product look good without actually lying. If they can promote off label, I won’t know what to believe. Then my strategy might be to stop seeing reps.

How Primary Care Docs Became Assistant Shoe Salesmen

Nurse practitioners, physician assistants, pharmacists and naturopaths have gained the right to prescribe medications traditionally only done by a physician. But the Medicare Therapeutic Shoe Bill requires that the physician managing the diabetic condition certify the need for footwear and inserts.

So although the podiatrist truly has the expertise in this arena, it falls on the patient’s primary care physician or endocrinologist to do the paperwork. Congress might have been concerned that because podiatrists profit from selling inserts or shoes, that someone else should determine whether it’s really needed. In fact, though, us primary care docs are overworked and don’t have much time to deal with such paperwork. If we deny that the patient needs it, especially after their podiatrist already told them they do, the patients get mad at us.

I think the best way to minimize fraud would be to have patients pay a portion of the cost, say 25%. That way they are less likely to get a shoe or insert unless they feel they really need it. Actually Medicare pays 80% of the allowable amount so patients pay up to 20% if they don’t have secondary insurance. Since most patients are going to buy a pair of shoes in any case, I think they should pay what a similar non-medical shoe would cost, and Medicare would pick up the difference. That way there would be no financial incentive for patients to get shoes they don’t really need, and doctors could stop being the watchdog.

At the very least, Congress should allow nurse practitioners and physician assistants to do the paperwork.